Hepatitis A Clinical Trial
Official title:
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.
Background: Infants with passively-transferred maternal antibody (PMA) to hepatitis A virus
(HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity
of hepatitis A vaccine among infants with and without PMA, vaccinated on different
schedules.
Methods: Infants were randomized to one of three groups, each receiving two doses of 720
EL.U. of hepatitis A vaccine (HAVRIX, Glaxo SmithKline) according to the following
schedules: Group 1 at ages 6 and 12 months; Group 2 at ages 12 and 18 months; Group 3 at
ages 15 and 21 months. We determined antibody to HAV (anti-HAV) status of mothers at the
time of delivery, and measured infants' anti-HAV concentrations at the time of the first
vaccine dose (baseline), and at 1, 7 and 12 months thereafter. Anti-HAV concentrations > 33
milli-International Units/milliliter (mIU/mL) were considered protective. We monitored
adverse reactions using diary cards and chart reviews.
Results: A total of 239 infants were enrolled, including 134 born to anti-HAV negative
mothers (Groups 1N, 2N, 3N) and 105 born to anti-HAV positive mothers (Groups 1P, 2P, 3P).
At month 12, 6 months after the second vaccine dose, the difference in GMC between Groups 1P
and 1N was the only statistically significant difference within groups (p<0.05). There were
no statistically significant differences in GMC among groups of infants born to anti-HAV
negative mothers ("N" groups), but the difference between Group 1P and Group 3P infants was
significant (p < 0.05). No serious adverse reactions related to vaccination were detected.
Conclusions: Hepatitis A vaccine is immunogenic among infants born to anti-HAV negative
mothers, and among those born to anti-HAV positive mothers and vaccinated beginning as young
as 12 months old. The persistence of PMA for at least six months among the majority of
infants born to anti-HAV positive mothers results in lower seroconversion rates and GMC's.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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